A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00396565
First received: November 3, 2006
Last updated: January 28, 2013
Last verified: January 2013

November 3, 2006
January 28, 2013
July 2006
November 2007   (final data collection date for primary outcome measure)
Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS). [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
The primary endpoint in this study is to be the change from baseline in total PANSS score. The primary evaluation time is to be at the final evaluation (when the evaluation was conducted finally in the subjects, i.e., at 6 weeks in LOCF data).
Complete list of historical versions of study NCT00396565 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
  • Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS]) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Responders are subjects with 30% or more reduction from baseline in total PANSS score. PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
  • Change From Baseline in Clinical Global Impression Scale (CGI-S) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe.
1 Proportion of responders;2 PANSS subscale score (positive symptoms, negative symptoms, general psychopathology, disorganized thoughts, hostility/ excitement, anxiety/ depression); 3 CGI-S
Not Provided
Not Provided
 
A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia

The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: ER OROS paliperidone
    Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.
  • Drug: Placebo
    Form= tablet, route= oral use. Two tablets once daily for 6 weeks.
  • Drug: Olanzapine
    Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.
  • Experimental: ER OROS paliperidone
    Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
    Intervention: Drug: ER OROS paliperidone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Olanzapine
    Intervention: Drug: Olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
394
November 2007
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have given their own consent in writing to participate in the study
  • Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)
  • Patients who have acute symptoms of schizophrenia
  • Both inpatients and outpatients are acceptable

Exclusion Criteria:

  • A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia
  • A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
  • Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or >120
  • Patients treated with three or more types of antipsychotic within 28 days before the screening test
  • Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
  • Patients with a complication of or a past history of cerebrovascular accident
  • Patients with a complication of or a past history of diabetes mellitus
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00396565
CR012625, JNS007ER-JPN-S31
Not Provided
Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
Not Provided
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP